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Drug Development: Stuck in a State of Puberty? Regulatory Reform of Human Clinical Research to Raise Responsiveness to the Reality of Human Variability |
Monday, May 27, 2013 |
10:00 AM–10:50 AM |
Auditorium Room 3 (Convention Center) |
Area: TBA; Domain: Theory |
CE Instructor: Nicole Luke, Ph.D. |
Chair: Nicole Luke (Surrey Place Centre) |
MICHAEL MALINOWSKI (Louisiana State University Law Center) |
Professor Michael J. Malinowski is the Ernest R. and Iris M. Eldred Endowed Professor of Law at Louisiana State University's Paul Hebert Law Center. He is a member of Phi Beta Kappa and Oxford University's 21st Century Trust, and he is a past chair of the Health and Human Services Committee, Administrative Law Section, of the American Bar Association and member of the ABA President's Special Committee on Bioethics. He received a B.A. summa cum laude from Tufts University and a J.D. from Yale Law School, where he was articles editor for the Yale Law Journal. Upon graduating from Yale, Professor Malinowski clerked first for Judge Emilio M. Garza and then for Chief Judge Carolyn Dineen King, U.S. Court of Appeals for the Fifth Circuit. He has published extensively on the commercialization of biotechnology and related health care and bioethics issues, and frequently lectures on these topics throughout the United States and abroad. |
Abstract: This article questions how prescription medicines reach the market and proposes law-policy reforms to enhance the FDA's science standard for human clinical trials and new drug approvals. The core message is that relying too heavily on clinical research data generated through the global "gold standard" of group experimental design--reliance on statistical analysis to compile and compare group averages--risks predicting little about the actual impact of prescription medicines on individuals, including members of the groups under study. This article introduces a law-policy methodology based upon commercial incentives and intervention by Congress and the FDA to raise the science standard for human clinical research, and to make drug development more closely parallel the reality of drug delivery in the practice of medicine. The objectives of this proposal are to promote several pressing needs: maximize drug performance and minimize adverse events; end the pattern of putting new prescription medications on the market with too much dependence on the medical profession to introduce meaningful clinical understanding of drugs through patient use over time; improve biopharmaceutical R&D decision making; align the regulatory standard with the infusion of added precision associated with contemporary genetics-based R&D; and realize more sound scientific information directly through the regulatory process to support the integrity of science in an age of academia industry integration, aggressive commercialization, secrecy in science, and constantly, rapidly evolving technology. |
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